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PDA TR 57-2

Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products

Report / Survey by Parenteral Drug Association , 03/01/2015

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Full Description

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish with, its qualification, which is a documented assessment of method performance. Guidance for analytical method development and analytical method qualification studies, such as risk-based strategies and priorities, analytical target profile and quality-by-design concepts, target performance criteria, and modern quality expectations is also included in this report.
 

Product Details

Published:
03/01/2015
ISBN(s):
9780939459742
Number of Pages:
59
File Size:
1 file , 700 KB
Product Code(s):
01057-2